Module 14 2022

22/03/2022

EU vs UK legislation

Active Implantable Medical Device Directive 90/385/EEC

Active Implantable Medical Device Directive 90/385/EEC

Medical Device Regulation 2017/745

In-Vitro Medical Device

In-Vitro Medical Device

UK MDR 2002

Directive 98/79/EC

Directive 98/79/EC

In Vitro Medical Device

Regulation 2017/746

Medical Device Directive 93/42/EC

Medical Device Directive 93/42/EC

The Organisation for Professionals in Regulatory Affairs

Diverging approaches to MD requirements – EEA and UK

5

Transition period

Brexit start

Jan 1, 2021

July 1, 2023

Only UKCA is authorized

Both CE & UKCA are authorized

EU Notified Body & UK Approved Body

Only UK Approved Body

The Organisation for Professionals in Regulatory Affairs

Diverging approaches to MD requirements – EEA and UK

6

3